| CTRI Number |
CTRI/2026/03/105213 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Early vs late entral feeding in gastrointestinal trauma |
|
Scientific Title of Study
|
Early vs Conventional Enteral Nutrition in Patients Undergoing Surgical Management for Traumatic Hollow Viscus Injuries – A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Bisan Bedi Gammey |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7007391842 |
| Fax |
|
| Email |
vishalgammey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh bagaria |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Trauma Surgery and critical care,
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
Division of Trauma Surgery and critical care,
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9914201918 |
| Fax |
|
| Email |
dr_bagaria@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh bagaria |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Division of Trauma Surgery and critical care,
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9914201918 |
| Fax |
|
| Email |
vishalgammey@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JPNATC, AIIMS, New Delhi |
| Address |
JPNATC, AIIMS, New Delhi 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Bisan Bedi Gammey |
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi |
Division of Trauma Surgery and critical care,
Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi
South
DELHI |
07007391842
vishalgammey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S364||Injury of small intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional entral nutrition |
treating doctor will decide when to allow entral feeding
entral nutrition started when bowel sounds appears , when patient start passing and faltus and fecus
entral nutriton started wih clear liquid diet , gradully to semisolid then solid ( conventional method )
|
| Intervention |
early enteral feeding |
enteral nutrition will be started within 24 hours of surgery
starting with liquid if tolerated then semisolid to solid diet
In first 24 hr
Volume & Frequency: 50–100 ml, 3–4 times over 24 hrs
If Tolerated: Continue same feeding for 24 hrs and reassess tolerance
If Not Tolerated: Stop oral feeds, maintain IV fluids, reassess after 12–24 hrs
24- 48 HR
NUTRITION & FEEDING PROTOCOL
Feeding Type: SEMI-SOLID SOFT DIET
Volume & Frequency: 100–150 g 3–4 times over 24 hrs
If Tolerated Advance to soft/full diet if tolerated
If Not Tolerated Reassess and gradually reintroduce semi-solid feeds
After 48- 72 hr
NUTRITION & FEEDING PROTOCOL
Feeding Type: SOFT FULL DIET
Volume & Frequency: As per tolerance, 3–4 times over 24 hrs
If Tolerated Continue normal diet as tolerated
If Not Tolerated Restart semi-solid diet after recovery of bowel function
After 72 hr
Full oral diet
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hemodynamically stable pt undergoing laparotomy for traumatic hollow viscus injury
Hemodynamically stable postoperatively
Pt with Stoma post operatively
Informed written consent obtained
|
|
| ExclusionCriteria |
| Details |
Pre-existing bowel pathology
Severe head injury (GCS less than8)
post operative open abdomen
Post operative organ support
Pregnancy
Unknownu unattended patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hollow viscus injury related length of hospital stay |
till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare time to return of bowel function
Compare anastomotic leak & reoperation rates
• SSI
• Intra abdomen abscess
• Compare 30-days mortality |
4 week |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a prospective randomized controlled trial comparing early (within 24 hours)
versus conventional enteral nutrition after surgery for post-traumatic hollow
viscus injury. A total of 132 adult patients undergoing emergency laparotomy
will be randomized into two groups. The primary outcome is length of hospital
stay related to hollow viscus injury, while secondary outcomes include return
of bowel function, postoperative complications. The study
aims to determine whether early enteral feeding is safe and leads to improved
recovery without increasing complications |